[News] RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS

[cyrial]

I just found out I have an affected DreamStation. Is there anything I can do to repair the device or mitigate the risk in the immediate term? Getting a prescription for a new device is going to take me months with the wait times for a sleep consult.

[WakeUpTime]

< above >

I assume you've now registered.  You likely won't have to wait the same 1-2 years that many of us waited, as they're at the final leg of replacements (in the U.S.), and they have likely built-up a more significant inventory of both new and refurbished units as replacements.

Regarding what to do in the mean time, that's complicated.  There are several options that are official and unofficial.  I'll only mention them and you'll need to investigate the options for your perspective.  Each has its own positives, negatives, cautions, risks and potential dangers.

- some people immediately stopped using their devices and just waited it out;  
- some people continued to use their recalled device for a year or two until their replacement system arrived;
- many people knew at the start of the recall knew that it would likely take many months to have a replacement and simply purchased another brand system;
- some people are capable of disassembling their systems and removing their foam using the youtube instructions;
- a small number of people have bought a foamless aftermarket plastic blower unit casing from an unknown seller;

That's my short action summary from about 267 pages of posts from ApneaBoard members, most of which were affected by the Recall.

[WakeUpTime]

40 More Deaths Reported in Philips Recall


https://sleepreviewmag.com/sleep-treatme...ps-recall/

The US Food and Drug Administration (FDA) updated its Philips Respironics recall safety communication to provide updated information about medical device reports that the agency received from Jan 1 to March 31.

The update indicates there have been over 6,000 medical device reports and 40 new deaths during that period.

[btreger]

40 More Deaths Reported in Philips Recall


https://sleepreviewmag.com/sleep-treatme...ps-recall/

Some additional information to go with the above post:

Those new additions bring the total number of MDRs that the FDA has collected between April 2021—when Philips first began alerting customers to potential issues with some of its respiratory devices—and the end of March of this year to more than 105,000, with 385 reported deaths.

Philips, FDA tally another 40 deaths stemming from CPAP recall (fiercebiotech.com)

[btreger]

Some additional information to go with the above post:

Those new additions bring the total number of MDRs that the FDA has collected between April 2021—when Philips first began alerting customers to potential issues with some of its respiratory devices—and the end of March of this year to more than 105,000, with 385 reported deaths.

Philips, FDA tally another 40 deaths stemming from CPAP recall (fiercebiotech.com)

Note: These numbers do appear in the link WakeUpTime provided. There is some additional info in the link I provided.

[TimaaaaaaaahRocks]

Each has its own positives, negatives, cautions, risks and potential dangers.

- some people immediately stopped using their devices and just waited it out;  
- some people continued to use their recalled device for a year or two until their replacement system arrived;
- many people knew at the start of the recall knew that it would likely take many months to have a replacement and simply purchased another brand system;
- some people are capable of disassembling their systems and removing their foam using the youtube instructions;
- a small number of people have bought a foamless aftermarket plastic blower unit casing from an unknown seller;

(missed one category)

- some people DIED before, during and after the five year wait for respironics to notify the public.

[btreger]

FIERCE

Biotech

Philips finds new head of recall-laden connected care segment in Pear Therapeutics exec

As Philips prepares to enter the third year of its recall of 5.5 million CPAP and BiPAP machines and other respiratory devices, the Dutch device-maker has appointed a new leader for its beleaguered connected care division.

Julia Strandberg will step into the role on April 24, Philips announced this week. She’ll be tasked with leading the company’s patient monitoring, enterprise informatics, and sleep and respiratory care businesses, the last of which is Respironics, the home of the ongoing recall.

Philips finds new head of recall-laden connected care segment (fiercebiotech.com)

[btreger]

About Lawsuits

Philips Evo Ventilator Recall Issued Due to Air Flow Malfunction Risk

An airflow sensor in the recalled Philips Trilogy Evo, Garbin Evo, and Aeris EVO ventilators may not detect the build-up of debris in the devices, which could lead to low blood oxygen, serious injuries, and death.

According to the new recall notice, Philips Respironics, Inc. sent out an urgent medical device correction letter to customers at the beginning of May, indicating air flow sensor problems may not detect environmental debris building up in the devices and blocking the flow of air to patients.

“Environmental debris may accumulate on the internal machine flow sensor causing partial occlusion which may impact accurate delivery of pressure, volume, or flow,” the recall notice indicates. “A malfunction caused by this issue can result in patient harm up to hypoxemia if not addressed by the care provider.”

Philips Evo Ventilator Recall Issued Due to Air Flow Malfunction Risk - AboutLawsuits.com

[btreger]

I just received the latest e-mail from Philips. I will assume that you will receive the same e-mail. I am going to post the main point they are trying to provide:

Philips 

This month we are sharing a message from David Ferguson, Business Leader of Philips Sleep and Respiratory Care as well as our latest test and research results for Philips Respironics CPAP devices and what it means for our patients.

The risk assessments have now been completed for the CPAP/BiPAP sleep therapy devices and results indicate that potential exposure to foam particulates and volatile organic compounds (VOCs) from the polyester-based polyurethane (PE-PUR) foam within the breathing gas pathway of these devices is unlikely to result in appreciable harm to health in patients.*

[btreger]

MD+DI

Philips Hit with Criminal Complaint in France

More than 200 people filed a criminal complaint in France last week in connection with Phillips' ongoing respiratory device recall.

Philips has been accused of involuntary manslaughter in a complaint filed in France late last week over faulty respiratory devices, including machines used for sleep apnea patients.

More than 200 people filed a complaint in France late last week, accusing the company of deceptive business practices, endangering the lives of others, and administering harmful substances, according to their lawyer, Christophe Lèguevaques. Three of the plaintiffs are accusing Philips of involuntary manslaughter, Lèguevaques said.

Philips Hit with Criminal Complaint in France (mddionline.com)